Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Thursday, May 23, 2013
Pallone Calls for Greater Clarity in Law Regulating Compounding Pharmacies
Washington, D.C. – Today, Congressman Frank Pallone, Ranking Member of the House Energy and Commerce Subcommittee on Health participated in a Hearing on “Examining Drug Compounding.” Since last year’s meningitis outbreak originating in a Massachusetts compounder that killed dozens and sickened hundreds, Pallone has called for hearings to be held on this issue affecting public safety.
An investigative report released last month upon the request of Pallone and Reps. John Dingell (MI-12), Henry A. Waxman (CA-33), Ed Markey (MA-05), and Diana DeGette (CO-01) found that these compounding pharmacies are going largely untracked, unregulated and under-inspected by states across America.
Pallone’s Opening Statement follows, as prepared for delivery:
Ranking Member Frank Pallone, Jr.
House Energy and Commerce Committee
Subcommittee on Health
Hearing on “Examining Drug Compounding”
May 23, 2013
Thank you Chairman Pitts. I am pleased that the Health Subcommittee is finally having a hearing to examine drug compounding. But unfortunately we are months behind. While we are having our first hearing today to gather information on this topic, our colleagues in the Senate have already worked together to produce and mark-up bipartisan legislation in the HELP Committee. This delay is regrettable.
Access to compounded drugs is crucial for patients who have unique medical needs. We know that the New England Compounding Center (NECC) that distributed the contaminated compounded product last year, resulting in the meningitis outbreak that claimed over 50 lives and infected over 700 patients, was a bad actor. However, NECC will not be the last bad actor. Similar tragedies will undoubtedly occur again unless we address the significant gaps that exist in the current regulation and oversight system of compounded products. If patients are to have confidence in the safety and quality of these drugs, we must ensure that compounders meet safety and quality standards.
While traditional compounders, who mix medications to fill a prescription for a specific person, are regulated at the state level and drug manufacturers are regulated by the federal government, there are a growing number of companies that do not fall into either of these categories. Many companies are compounding drugs without prescriptions and shipping large quantities of the products across state lines, in essence acting more like manufacturers than traditional compounders. In the absence of clear lines of authority, these companies experience very little state or federal oversight.
As we begin to examine drug compounding, I urge my colleagues to use this as an opportunity to move forward to determine what changes are needed, rather than looking back and casting blame. We must stop questioning whether FDA needs new authority. In fact, in the past few months of examination by our Oversight Subcommittee and the Senate HELP Committee, it has been made abundantly clear that conflicting court opinions and ambiguous language in the law, shows that the FDA does not have adequate authority to oversee compounders.
That is why I support efforts to help identify a new category of companies to be subject to federal regulation and oversight, and provide FDA the tools and resources it needs to properly regulate them.
Mr. Chairman, I hope today can be the start to this Committee coming together in a bipartisan manner to address this issue and create greater clarity in the law so that tragedies like the one involving NECC do not happen again. The American people deserve certainty that the drugs they receive are safe and effective.
Thank you to all our witnesses for being here. I look forward to hearing about how Congress can best address the gaps in regulation and oversight that were unfortunately highlighted by the NECC meningitis outbreak and how all stakeholders can work together to protect the public health.